(63 days)
The purpose and function of the Mediana ARGUS VCM vital signs monitor is to monitor non-invasive blood pressure (systolic, diastolic, and mean arterial pressures), functional arterial oxygen saturation, pulse rate for adult, pediatric and neonate patients and temperature for adult and pediatric patients in all hospital areas and hospital-type facilities. It may be used during hospital transport and in mobile, land-based environments, such as ambulances, within the specification of the environmental characteristics.
- Note: Hospital use typically covers such areas as general care floors, operating rooms, special procedure areas, intensive and critical care areas, within the hospital plus hospital-type facilities. Hospital-type facilities include physician office based facilities, sleep labs, skilled nursing facilities, surgicenters, and sub-acutecenters.
- Note: Intra-hospital transport includes transport of a patient within the hospital or hospital-type facility.
The ARGUS VCM vital signs monitor is to monitor non-invasive blood pressure, pulse rate, non-invasive functional oxygen saturation of arterial hemoglobin (SpO2) for adult, pediatric and neonate patients and body temperature for adult and pediatric patients in general hospital and alternate care facilities by medically trained personnel. This monitor is available for sale only upon the order of a physician or licensed health care professional.
The Mediana ARGUS VCM vital signs monitor is a lightweight and compact device (180×278×130 mm and 2.7 kg) powered by AC mains (100-240VAC, 50-60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on 7segment and LED displays.
The provided text is a 510(k) Summary of Safety and Effectiveness for the Mediana ARGUS VCM series, Vital Signs Monitor. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with specific acceptance criteria and performance metrics of the new device itself.
Therefore, much of the requested information cannot be extracted directly from this document. Here's what can be inferred and what is explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria with numerical targets and the Mediana ARGUS VCM series' specific performance against these targets. Instead, it relies on demonstrating substantial equivalence to predicate devices by stating that its specifications and performance are equivalent to those predicate devices.
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Non-Invasive Blood Pressure (NIBP) measurement specifications and performance | Equivalent to Welch Allyn Protocol vital signs monitors, Model 53000 Series and Model Propaq LT 802 Series. | Stated as "equivalent to the Welch Allyn Protocol vital signs monitors, Model 53000 Series and Model Propaq LT 802 Series." |
| Pulse rate specifications and performance (derived from NIBP or SpO2) | Equivalent to Welch Allyn Protocol vital signs monitors, Model 53000 Series, and Nellcor Puritan Bennett Pulse Oximeter Model N-550. | Stated as "equivalent to the Welch Allyn Protocol vital signs monitors, Model 53000 Series, and the Nellcor Puritan Bennett Pulse Oximeter Model N-550." |
| Pulse Oximetry (SpO2) specifications and performance | Equivalent to Nellcor Puritan Bennett Pulse Oximeter Model N-550. | Stated as "equivalent to the Nellcor Puritan Bennett Pulse Oximeter Model N-550." |
| Temperature specifications and performance | Equivalent to Welch Allyn Protocol vital signs monitors, Model 53000 Series and the Vital Signs Monitor (VSM). | Stated as "equivalent to the Welch Allyn Protocol vital signs monitors, Model 53000 Series and the Vital Signs Monitor (VSM)." |
Explanation: The "acceptance criteria" here are implied to be the performance characteristics of the predicate devices. The "reported device performance" is a statement of equivalence rather than specific numerical results. The document explicitly states that the Mediana device uses the same NIBP module (Welch Allyn NIBP module POEM), the same SpO2 module (Nellcor Oximetry module MP506), and the same temperature module (Welch Allyn thermometry module SureTemp®) as its predicate devices, which is the primary basis for claiming equivalence in these specific areas.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document mentions "system V & V plan (#PA300-09000) and summary (#PA300-09013)" were used, but details on sample size for testing are not included in this summary.
- Data Provenance: Not specified. The context suggests that the testing would have been conducted by Mediana Co., Ltd. in Korea, but no details on the origin of any clinical data (e.g., country of origin, retrospective or prospective) are provided. The testing primarily appears to be technical verification and validation, rather than a clinical study with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a study involving expert-established ground truth for the device's performance. The "ground truth" for demonstrating equivalence is based on the specifications and performance of the predicate and the use of the same core measurement modules.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication method is typically used in AI/diagnostic imaging studies for establishing ground truth, which is not the nature of the testing described here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/diagnostic imaging device. It is a vital signs monitor, and the studies mentioned are focused on demonstrating technical performance and equivalence, not comparing human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a way. The "performance testing" described ("system V & V plan (#PA300-09000) and summary (#PA300-09013)") would assess the device's functional performance in isolation, independent of human interaction beyond operating the device. However, this is not in the context of an "algorithm only" as typically understood in AI devices. It refers to the performance of the integrated vital signs monitor.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" implicitly used for the claim of substantial equivalence is the established and legally marketed performance of the predicate devices, particularly when the same core measurement modules are utilized. For technical verification and validation, the ground truth would be precise reference measurements from calibrated equipment (e.g., for blood pressure, SpO2, and temperature).
8. The sample size for the training set
Not applicable. This device is not an AI algorithm that requires a training set. Its design is based on established vital signs monitoring technologies, some of which are explicitly stated to be the same modules as in the predicate devices.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
JUL 2 8 2005
510(k) Summary of Safety and Effectiveness
Submitter
Mediana Co.,Ltd. 231-6 Nonhyun-Dong, Kangnam-Ku, Seoul, Korea 135-010 Tel) +822-542-3375 Fax) +822-542-1621 Company Contact: Gina Y.J.LEE, Specialist of Regulatory Affairs Date Summary Prepared: March 2nd, 2005
Device Name
| Trade Name: | ARGUS VCM series, Vital Signs Monitor |
|---|---|
| Common Name: | Vital signs measurement devices |
| Classification Name: | NIBP measurement system (21CFR870.1130), also containsnon-invasive pulse oximetry, SpO2 (21CFR870.2700) andclinical electronic thermometer (21CFR870.2910) |
| Classification: | Class II |
Predicate Devices (Legally Marketed Devices)
The predicate devices for Vital signs monitors, Model ARGUS VCM series are:
- Welch Allyn Protocol Inc. Vital Signs Monitors, Model 53000 Series cleared by FDA through 510(k) No. K031740, and
- Welch Allyn Protocol Inc. Vital signs Monitors, Model Propaq LT 802 Series cleared by FDA through 510(k) No. K033378, and
- Nellcor Puritan Bennett (division of Tyco Healthcare Inc.) Pulse Oximeter, Model N-550 cleared by FDA through 510(k) No. K021090, and
- Welch Allyn Inc. Vital Signs Monitors, Welch Allyn Vital Signs Monitor (VSM), cleared by FDA through 510(k) No. K024005.
Device Description
The ARGUS VCM vital signs monitor is to monitor non-invasive blood pressure, pulse rate, non-invasive functional oxygen saturation of arterial hemoglobin (SpO2) for adult, pediatric and neonate patients and body temperature for adult and pediatric patients in general hospital and alternate care facilities by medically trained personnel. This monitor is available for sale only upon the order of a physician or licensed health care professional.
The Mediana ARGUS VCM vital signs monitor is a lightweight and compact device (180×278×130 mm and 2.7 kg) powered by AC mains (100-240VAC, 50-60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on 7segment and LED displays.
Intended Use
The purpose and function of the Mediana ARGUS VCM vital signs monitor is to monitor noninvasive blood pressure (systolic, diastolic, and mean arterial pressures), functional arterial oxygen saturation, pulse rate for adult, pediatric and neonate patients and temperature for adult and pediatric patients in all hospital areas and hospital-type facilities. It may be used during hospital transport and in mobile, land-based environments, such as ambulances, within the specification of the environmental characteristics.
{1}------------------------------------------------
- Note: Hospital use typically covers such areas as general care floors, operating rooms, special procedure areas, intensive and critical care areas, within the hospital plus hospital-type facilities. Hospital-type facilities include physician office based facilities, sleep labs, skilled nursing facilities, surgicenters, and sub-acutecenters.
- Note: Intra-hospital transport includes transport of a patient within the hospital or hospitaltype facility.
Summary of Technical Characteristics of the Device Compared to the Predicate Devices (Legally Marketed Devices)
The Mediana vital signs monitors, Model ARGUS VCM Series are substantially equivalent to the Welch Allyn Protocol vital signs monitors, Model 53000 Series and Model Propaq LT 802 Series, Nellcor Puritan Bennett (division of Tyco Healthcare Inc.) Pulse Oximeter Model N-550, and Welch Allyn Inc. Vital Signs Monitor, Welch Allyn Vital signs Monitor (VSM).
- The Non-Invasive Blood Pressure (NIBP) measurement specifications and performance are equivalent to the Welch Allyn Protocol vital signs monitors, Model 53000 Series and Model Propaq LT 802 Series. Welch Allyn NIBP module POEM is the same NIBP module used in the Mediana vital signs monitors, Model ARGUS VCM Series.
- The Pulse rate specifications and performance derived from either Non-Invasive Blood Pressure (NIBP) or Pulse Oximetry (SpO2) are equivalent to the Welch Allyn Protocol vital signs monitors, Model 53000 Series, and the Nellcor Puritan Bennett Pulse Oximeter Model N-550.
- The Pulse Oximetry (SpO2) specifications and performance are equivalent to the Nellcor Puritan Bennett Pulse Oximeter Model N-550. Nellcor Oximetry module MP506 is the same SpO2 module used in the Mediana vital signs monitors, Model ARGUS VCM Series.
- The Temperature specifications and performance are equivalent to the Welch Allyn Protocol vital signs monitors, Model 53000 Series and the Vital Signs Monitor (VSM). Welch Allyn thermometry module SureTemp® is the same temperature module used in the Mediana vital signs monitors, Model ARGUS VCM Series.
Summary of Performance Testing
The Mediana vital signs monitors, Model ARGUS VCM Series substantially have been tested in accordance with the system V & V plan (#PA300-09000) and summary (#PA300-09013) included with the submission using production equivalent units prior to release to market.
A risk analysis identifying potential hazards and documenting mitigation of the hazards has been developed and applied as part of Mediana design control procedure. Mediana's quality system confirms to 21CFR820, ISO 9001, ISO13485 and CMDCAS ISO 13485 certified by DNV (Det Norske Veritas) and NSAI (National Standards Authority of Irelands).
Conclusions
As stated above, the Mediana vital signs monitors, Model ARGUS VCM Series are safe and effective and comply with the appropriate medical device standards and are substantially equivalent to the earlier identified predicate devices.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S.A." arranged around the perimeter. Inside the circle is an abstract symbol resembling three human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mediana Co., LTD. c/o Mr.Charlie Mack International Regulatory Consultants 231-6 Nonhyun-Dong Kangnam-Ku, Seoul, Kerea 135-110
Re: K051375
Trade Name: Argus VCM series, vital signs monitors Regulation Number: 21 CFR 870.1130, 21 CFR 870.2700, 21 CFR 880.2910 Regulation Name: System, Measurement, Blood Pressure, Non-Invasive Regulatory Class: Class II (two) Product Code: DXN Dated: May 24, 2005 Received: May 26, 2005
Dear Mr. Mack:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
JUL 2 8 2005
{3}------------------------------------------------
Page 2 - Mr.Charlie Mack
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0295. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bfimmermon for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): K051375
Device Name: Arqus VCM Series, Vital Signs Monitor
Indications For Use: The purpose and function of the Mediana ARGUS VCM vital signs monitor is to monitor non-invasive blood pressure (systolic, diastolic, and mean arterial pressures), functional arterial oxygen saturation, pulse rate for adult, pediatric and neonate patients and temperature for adult and pediatric patients in all hospital areas and hospital-type facilities. It may be used during hospital transport and in mobile, land-based environments, such as ambulances, within the specification of the environmental characteristics.
- Note: Hospital use typically covers such areas as general care floors, operating rooms, special procedure areas, intensive and critical care areas, within the hospital plus hospital-type facilities. Hospital-type facilities include physician office based facilities, sleep labs, skilled nursing facilities, surgicenters, and sub-acutecenters.
- Note: Intra-hospital transport includes transport of a patient within the hospital or hospital-type facility.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Hammonds
ivision Sign-Off) Division of Cardlovascular Devices KOSIS IS 510(k) Number__
Page 1 of 1
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).